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FDA 510(k)

Cerafix Dura Substitute

K-Number: K172603 · 2017-11-27

ApplicantAcera Surgical, Inc.
Decision Date2017-11-27
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cerafix Dura Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2017-11-27 under 510(k) number K172603. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cerafix Dura Substitute?

Cerafix Dura Substitute is a medical device that received FDA 510(k) clearance on 2017-11-27. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K172603.

When did Cerafix Dura Substitute receive FDA 510(k) clearance?

Cerafix Dura Substitute received FDA 510(k) clearance on 2017-11-27, under 510(k) number K172603.

Who is the listed applicant for Cerafix Dura Substitute?

The FDA 510(k) record lists Acera Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cerafix Dura Substitute?

The FDA product code for Cerafix Dura Substitute is GXQ.

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Other records listing Acera Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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